Progress on Stem Cell Research Stalling in U.S. Due to Current Administration Policy

8/8/2003

From: Julie Kimbrough, 212-585-3501, or Maggie Goldberg, 973-379-2690 ext. 115, both of the Coalition for the Advancement of Medical Research

WASHINGTON, Aug. 8 -- Two years after the President's decision on whether or not to allow federal funding for embryonic stem cell research (August 9, 2001), scientists, patient groups, and universities agree that progress in the U.S. is stalling due to the limited scope of the Administration's policy.

The current policy, which allows federal funds to be used only on stem cell lines derived before August 9, 2001, has hindered critical research advances from being made. Embryonic stem cell research could help over 100 million Americans affected by life-threatening diseases and conditions such as cancer, Alzheimer's, diabetes, Parkinson's, spinal cord injuries, ALS, and many others.

"These past two years have only made it clearer that the promise of stem cell research is so strong that the restrictive policy must be changed," said Michael Manganiello, president of the Coalition for the Advancement of Medical Research (CAMR). CAMR, comprised of nationally recognized patient groups, universities, and scientific societies, led the charge to support federal funding of stem cell research and has led the efforts opposing a ban on therapeutic cloning.

"The only thing we know for sure is that the President's policy has caused U.S. federally-funded researchers to be forced to drive in the slow lane while the rest of the world speeds by," said Larry Goldstein, PhD, professor of cellular and molecular medicine, UCSD. Some of the major issues with the current stem cell policy are:

-- Only 11 of the 78 promised stem cell lines on the National Institutes of Health (NIH) registry are available for researchers, and the lines are not genetically or racially diverse enough to meet researcher needs;

-- The NIH is projecting to spend only $17 million in 2003 for human embryonic stem cell research, far short of the $100 million advocated by Secretary Thompson;

-- The National Cancer Institute is projecting $0 funding for human embryonic stem cell research in 2003, despite statements by top cancer researchers that human embryonic stem cell research has great potential for advancing research in their field;

-- Developing therapies for patients from the available stem cell lines may prove difficult since the lines were made using mouse feeder cells and bovine serums, and are thus potentially subject to FDA xenotransplantation regulations. Researchers are also hesitant to use these lines for patient therapies when uncontaminated lines are being developed in the private sector and in other countries;

-- The U.S. is falling behind other countries that are making more progress with embryonic stem cell research. The U.K. has even taken the lead in chairing the international meetings of key stem cell funding agencies.

"Stem cell research may be the key to unlocking the mystery of ALS. While we are closer, I don't have years to wait for a cure, we must push the envelope now," said Andrew Knipe, who was diagnosed with ALS three years ago. ALS, more commonly known as Lou Gehrig's disease, attacks nerve cells and pathways in the brain and spinal cord. It is always fatal and the average life-expectancy for someone with the disease is two to five years from time of diagnosis. If successful, stem cell transplants could help grow new connections between nerves and muscles and help ALS patients regain motor function.

"It's frustrating that as new data trickle out reinforcing the obvious potential of this important line of research, it's so apparent that we are only scratching the surface because of the extreme complications and limitations imposed by the Administration's policy. The combination of a restrictive policy and a lot of red tape continues to bar many of our best scientists from switching their research focus to this very important field," added Dr. Goldstein.

"Our coalition has worked diligently with the Administration and the National Institutes of Health (NIH) to ensure that the President's policy be implemented to its fullest potential but the policy is just too restrictive. While the NIH should be applauded for developing the Stem Cell Registry, establishing high-quality training programs to encourage scientists to pursue the research, and its genuine good faith efforts, progress is just not moving fast enough. This policy must be expanded to allow research on stem cell lines derived after August 9, 2001," added Manganiello.

The Coalition for the Advancement of Medical Research (CAMR), is comprised of nationally-recognized patient organizations, universities, scientific societies, foundations, and individuals with life-threatening illnesses and disorders, advocating for the advancement of breakthrough research and technologies in regenerative medicine -- including stem cell research and somatic cell nuclear transfer -- in order to cure disease and alleviate suffering. For more information on CAMR, visit the website: http://www.camradvocacy.org.